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Amiodarone hydrochloride is a potent antiarrhythmic drug used to treat and prevent severe, life-threatening irregular heartbeats (arrhythmias).
Its primary uses include managing ventricular tachycardia/fibrillation and maintaining normal rhythm in atrial fibrillation when other treatments fail. It is administered both intravenously in emergencies and orally for long-term therapy.
A critically important feature is its high toxicity potential. Serious side effects require regular monitoring and limit its use to serious cases. These include lung damage (pneumonitis), liver toxicity, thyroid dysfunction (both over- and under-active), and skin photosensitivity. It has an extremely long half-life, lasting weeks in the body.
It is considered a highly effective but last-resort medication due to its significant risk profile, reserved for situations where its benefits clearly outweigh its dangers.
Items | Specifications | Results |
Appearance | White or almost white,fine, crystalline powder | Almost white,fine,crystalline powder |
Solubility | Very slightly soluble in water, freely soluble in methylene chloride,soluble in methanol, sparingly soluble in ethanol (96 percent). | Very slightly soluble in water, freely soluble in methylene chloride,soluble in methanol, sparingly soluble in ethanol (96 percent). |
Identification | A)IR :Conforms to Amiodarone Hydrochloride CRS | Conforms |
B)Chlorides :It gives reaction of chlorides | Conforms | |
Appearance of Solution | The solution is clear | Clear |
Not more than GY₅or BY₅ | Less than GY₅ | |
PH | 3.2 to 3.8 | 3.5 |
Loss on Drying | ≤0.5% | 0.04% |
Sulphated Ash | ≤0.1% | 0.03% |
Iodides | ≤150 ppm | <150 ppm |
Impurity H | ≤0.02% | <0.02% |
Related Substances | Impurity A: ≤0.2% | ≤0.01% |
Impurity B: ≤0.2% | 0.04% | |
<0.01% | ||
Impurity D: ≤0.2% | ||
<0.01% | ||
Impurity F: ≤0.2% | ||
Impurity G: ≤0.2% | <0.01% | |
Unspecified Impurities: ≤0.10% | 0.02% | |
Total Impurities: ≤0.5% | 0.07% | |
Ethanol | ≤5000 ppm | 502 ppm |
Toluene | ≤890 ppm | <80 ppm |
Assay | 98.5%to 101.0%(dried substance) | 100.7% |
Conclusion | The product conforms to the above specifications. | |
Amiodarone hydrochloride is the hydrochloride salt form of amiodarone, a potent Class III antiarrhythmic medication. It is used primarily to treat and prevent serious, life-threatening cardiac arrhythmias (irregular heartbeats).
It is indicated for ventricular and supraventricular arrhythmias that are recurrent or resistant to other therapies, including:
Ventricular Fibrillation (VF) & Ventricular Tachycardia (VT): Especially for prevention in high-risk patients.
Atrial Fibrillation (AF) and Flutter: To maintain normal sinus rhythm (chemical cardioversion and long-term maintenance).
Other Supraventricular Tachycardias (SVTs): When standard treatments are ineffective or contraindicated.
Mechanism: It works primarily by prolonging the cardiac action potential and refractory period (Class III effect), but also has Class I, II, and IV properties, making it a very broad-spectrum antiarrhythmic.
Administration:
Intravenous (IV): Used in hospital settings for acute, life-threatening arrhythmias.
Oral: Used for long-term maintenance therapy.
Notable Properties: It has an exceptionally long half-life (up to several weeks), requiring a loading dose regimen. It also has significant lipophilicity (fat solubility).
Due to its potency, amiodarone has a high risk of serious, sometimes irreversible side effects, necessitating careful patient monitoring. Major concerns include:
Pulmonary Toxicity: Interstitial pneumonitis, which can be fatal.
Thyroid Dysfunction: Can cause both hypothyroidism and hyperthyroidism.
Hepatotoxicity: Liver enzyme elevations and, rarely, hepatitis.
Cardiac Effects: Can paradoxically cause bradycardia (slow heart rate) and, rarely, worsen arrhythmias.
Other: Skin photosensitivity (blue-grey discoloration), corneal microdeposits, and neuropathic effects.
In summary, amiodarone hydrochloride is a highly effective but potentially toxic "drug of last resort" for managing severe cardiac arrhythmias, reserved for cases where the benefits outweigh its significant risks. Its use requires careful ongoing clinical and laboratory monitoring.



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